古代经典名方中药新药研发策略及清肺排毒颗粒上市实践分析  

Research and Development Strategy of New Medicine of Ancient Classical Prescriptions and the Registration Example of Qingfei Paidu Granules(清肺排毒颗粒)

作　　者：李安 刘斌 宗星煜 龚照元 白卫国[1] 田元祥[1] 王希猛 王燕平[1] 史楠楠[1] LI An;LIU Bin;ZONG Xingyu;GONG Zhaoyuan;BAI Weiguo;TIAN Yuanxiang;WANG Ximeng;WANG Yanping;SHI Nannan(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing,100700)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京市100700

出　　处：《中医杂志》2021年第21期1890-1894,共5页Journal of Traditional Chinese Medicine

基　　金：新型冠状病毒感染肺炎中医药应急专项(2020ZYL-CYJ07-1)。

摘　　要：2020版《药品注册管理办法》增加了古代经典名方注册单独分类和人用经验评价证据,并建立了中医药理论、人用经验、临床试验"三结合"的审评证据体系。清肺排毒颗粒按照中药注册分类3.2类路径和"三结合"审评证据体系要求进行了具体实践,并于2021年3月2日获批上市。从行政文件、药品信息及概要,药学及药理毒理研究,临床研究三部分分析古代经典名方中药复方制剂新药申报特点,梳理"三结合"在申报资料中的具体体现,并对清肺排毒颗粒上市这一具体实践进行论述,旨在为古代经典名方中药新药研发提供可行策略和参考模式。The registry category of ancient classical prescriptions and the evidence evaluation based on human experience have been added in the revised Provisions for Drug Registration issued on 2020.Moreover,an evidence evaluation system combining traditional Chinese medicine theory,human experience,and clinical trials evidence(abbreviated as"three-in-one"system)has been advocated.By following the provision 3.2 of registration of Chinese herbal medicine and adopting the"three-in-one"system,Qingfei Paidu Granules(清肺排毒颗粒)has been approved for marketing on March 2nd,2021.This paper summarized the registration characteristics of ancient classical prescriptions from three aspects including administrative documents,drug information and summary;pharmacy,pharmacology and toxicology researches;and clinical researches.The reflection of the"three-in-one"system in the registration materials were also analyzed,and the registration example of Qingfei Paidu Granules was introduced,thereby providing references for the research and development of new medicine of traditional Chinese medicine.

关 键 词：药品注册管理 审评证据体系 古代经典名方 中药新药研发 清肺排毒颗粒 

分 类 号：R288[医药卫生—中药学]